Filgrastim in Patients with Chemotherapy-Induced Febrile Neutropenia: A Double-Blind, Placebo-Controlled Trial

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Abstract
To determine if filgrastim (recombinant human methionyl granulocyte colony-stimulating factor) used in addition to standard inpatient antibiotic therapy accelerated recovery from infection associated with chemotherapy-induced neutropenia. Randomized, double-blind, placebo-controlled trial. Hematology and oncology wards of four teaching hospitals. 218 patients with cancer who had fever (temperature >38.2 °C) and neutropenia (neutrophil count 9/L) after chemotherapy. Patients were randomly assigned to receive filgrastim (12 µg/kg of body weight per day) (n = 109) or placebo (n = 107) beginning within 12 hours of empiric therapy with tobramycin and piperacillin. Patients received treatment and remained in the study until the neutrophil count was greater than 0.5 × 109/L and until 4 days without fever (temperature P = 0.02). In exploratory subset analyses, filgrastim appeared to provide the greatest benefit in patients with documented infection and in patients presenting with neutrophil counts of less than 0.1 × 109/L. Filgrastim treatment used with antibiotics at the onset of febrile neutropenia in patients with cancer who have received chemotherapy accelerated neutrophil recovery and shortened the duration of febrile neutropenia.

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